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Last Updated: November 22, 2024

ACETAMINOPHEN; BUTALBITAL - Generic Drug Details

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What are the generic drug sources for acetaminophen; butalbital and what is the scope of freedom to operate?

Acetaminophen; butalbital is the generic ingredient in twenty branded drugs marketed by Forest Pharms, Mallinckrodt, Dr Reddys Labs Sa, Granules, Valeant, Dunhall, Larken Labs Inc, Alvogen, Halsey, Lgm Pharma, Mikart, Ne Rx Pharma, Quagen, Senores Pharms, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Hikma, Key Therap, Lannett Co Inc, Novast Labs, Nuvo Pharms Inc, Taro, Us Chem, Abhai Llc, Able, Actavis Labs Ut Inc, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, Hikma Intl Pharms, and Nostrum Labs Inc, and is included in eighty-two NDAs. Additional information is available in the individual branded drug profile pages.

Eleven suppliers are listed for this compound.

Summary for ACETAMINOPHEN; BUTALBITAL

US Patents:	0
Tradenames:	20
Applicants:	39
NDAs:	82
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Patent Applications:	8
DailyMed Link:	ACETAMINOPHEN; BUTALBITAL at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; BUTALBITAL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
GlaxoSmithKline	Phase 3

See all ACETAMINOPHEN; BUTALBITAL clinical trials

Pharmacology for ACETAMINOPHEN; BUTALBITAL

Drug Class	Barbiturate

US Patents and Regulatory Information for ACETAMINOPHEN; BUTALBITAL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lgm Pharma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	076560-002	Jul 19, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Ut Inc	FIORICET W/ CODEINE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	020232-001	Jul 30, 1992	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040267-001	Jul 30, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Halsey	BUTALBITAL AND ACETAMINOPHEN	acetaminophen; butalbital	TABLET;ORAL	089568-001	Oct 5, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Quagen	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	216376-001	Mar 12, 2024	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Key Therap	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	206615-001	Aug 4, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mirror Pharms Llc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040883-001	Dec 23, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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